The present invention relates generally to a wound dressing, and more particularly, to a wound dressing that is a multi-layer, elastic bandage that may be compressively wrapped around a wound and is capable of absorbing fluids and wound exudate while preventing the absorption of external liquids through the bandage. When permeation of moisture vapor is desired, proper selection of the materials can maintain the liquid barrier properties while allowing breathability of moisture vapor.
In the field of medicine, wrappings or bandages have long been used to prevent injury, in addition to providing for protection against re-injury. For example, limbs are wrapped to prevent injury or re-injury to skin, tendons, muscles and/or ligaments as well as to provide support. Similarly, adherent articles, such as bandages or adhesive tapes are commonly used to cover wounds, cuts, blisters, and the like. Such adherent articles typically include an adhesive material that is applied to or used in conjunction with a substrate material. For example, to use an adherent article a portion of the substrate material is positioned over the wound and an adhesive portion either previously conjoined to the substrate or placed over the substrate is adhered to the surrounding skin. The adherence of the substrate material to the skin allows the adherent article to be tightly fitted over the wound to protect the wound from infection.
A widely acceptable form of treatment for chronic leg ulcers is compression therapy. Wrapping products are typically employed so as to apply a pressure of less than about 3 pounds per square inch to the area wrapped. Lower pressures such as, for example, about 1 psi are desirable. In contrast, wraps which exert substantial pressure can cause circulation problems. Further, if the material is folded or creased while being applied, the bandage might provide uneven support or have high tension areas. This ultimately could cause circulation problems in the user""s leg. There is often a need to combine compression therapy with the use of an absorbent article. Problems associated with absorbent articles relate to positioning and securing them over a wound bed. Further, when an absorbent article is used, it often must be forcibly torn away from the skin to break the adhesive bond of the substrate with the skin. This frequently results in substantial pain to the user and possible maceration of the wound itself.
The term xe2x80x9celasticxe2x80x9d is used herein to mean any material which, upon application of a biasing force, is stretchable, that is, elongatable at least about 60 percent (i.e., to a stretched, biased length which is at least about 160 percent of its relaxed unbiased length), and which, will recover at least 55 percent of its elongation upon release of the stretching, elongating force. A hypothetical example would be a one (1) inch sample of a material which is elongatable to at least 1.60 inches and which, upon being elongated to 1.60 inches and released, will recover to a length of not more than 1.27 inches. Many elastic materials may be elongated by much more than 60 percent (i.e., much more than 160 percent of their relaxed length), for example, elongated 100 percent or more, and many of these will recover to substantially their initial relaxed length, for example, to within 105 percent of their original relaxed length, upon release of the stretching force.
The term xe2x80x9cinelasticxe2x80x9d or xe2x80x9cnonelasticxe2x80x9d as used herein refers to any material which does not fall within the definition of xe2x80x9celastic,xe2x80x9d above.
As used herein the term xe2x80x9cextensiblexe2x80x9d means elongatable or stretchable in at least one direction.
The term xe2x80x9cmachine directionxe2x80x9d as used herein refers to the planar dimension of a nonwoven fibrous web which is in the direction of travel of the forming surface onto which fibers are deposited during formation of the web.
The term xe2x80x9ccross-machine directionxe2x80x9d as used herein refers to the planar dimension of a nonwoven fibrous web which is in the direction that is perpendicular to the machine direction defined above.
The term xe2x80x9cz-directionxe2x80x9d as used herein refers to the thickness direction of a sheet of material, that is, the direction perpendicular to the plane of the length and width dimensions.
As used herein, the term xe2x80x9cdisposablexe2x80x9d is not limited to single use articles but also refers to articles that can be discarded if they become soiled or otherwise unusable after only a few uses.
The term xe2x80x9ccomposite elastic materialxe2x80x9d as used herein refers to an elastic material which may be a multi-component material or a multilayer material. For example, a multilayer material may have at least one elastic layer joined to at least one gatherable layer so that the gatherable layer is gathered between the locations where it is joined to the elastic layer. Such a multilayer composite elastic material may be stretched to the extent that the nonelastic material gathered between the bond locations allows the elastic material to elongate. This type of multilayer composite elastic material is disclosed, for example, by U.S. Pat. No. 4,720,415 to Vander Wielen et al., issued Jan. 19, 1988, and U.S. Pat. No. 6,096,668 to Abuto et al., issued Aug. 1, 2001, and a process for making the same is disclosed, for example, by U.S. Pat. No. 5,964,973 to Heath et al., issued Oct. 12, 1999, all of which are hereby incorporated by reference.
The term xe2x80x9cstretch-to-stopxe2x80x9d as used herein refers to a ratio determined from the difference between the unextended dimension of a composite elastic material and the maximum extended dimension of a composite elastic material upon the application of a specified tensioning force and dividing that difference by the unextended dimension of the composite elastic material. If the stretch-to-stop is expressed in percent, this ratio is multiplied by 100. For example, a composite elastic material having an unextended length of 5 inches and a maximum extended length of 10 inches upon applying a force of 2000 grams has a stretch-to-stop (at 2000 grams) of 100 percent.
The term xe2x80x9cmeltspunxe2x80x9d as used herein refers to a nonwoven web of filaments or fibers, which are formed by extruding a molten thermoplastic material, or coextruding more than one molten thermoplastic material, as filaments or fibers from a plurality of fine, usually circular, capillaries in a spinneret with the diameter of the extruded filaments or fibers. Meltspun fabrics include, but are not limited to, spunbonded fabrics and meltblown fabrics and are characterized as having thermal bonding junctions throughout the fabric.
As used herein, the terms xe2x80x9cnonwovenxe2x80x9d and xe2x80x9cnonwoven webxe2x80x9d mean a web having a structure of individual fibers or threads which are interlaid, but not in an identifiable, repeating manner. Nonwoven webs have been, in the past, formed by a variety of processes such as, for example, meltblowing processes, spunbonding processes and bonded carded web processes.
As used herein, the term xe2x80x9cautogenous bondingxe2x80x9d means bonding provided by fusion and/or self-adhesion of fibers and/or filaments without an applied external adhesive or bonding agent. Autogenous bonding may be provided by contact between fibers and/or filaments while at least a portion of the fibers and/or filaments are semi-molten or tacky. Autogenous bonding may also be provided by blending a tackifying resin with thermoplastic polymers used to form fibers and/or filaments. Fibers and/or filaments formed from such a blend can be adapted to self-bond with or without the application of pressure and/or heat. Solvents may also be used to cause fusion of fibers and filaments which remains after the solvent is removed.
As used herein, the terms xe2x80x9cmeltblownxe2x80x9d, xe2x80x9cmeltblown fibersxe2x80x9d, and xe2x80x9cmeltblown filamentsxe2x80x9d mean fibers formed by extruding a molten thermoplastic material through a plurality of fine, usually circular, die capillaries as molten threads or filaments into a high velocity gas (e.g. air) stream which attenuates the filaments of molten thermoplastic material to reduce their diameter, which may be to microfiber diameter. Thereafter, the meltblown fibers are carried by the high velocity gas stream and are deposited on a collecting surface to form a web of randomly disbursed meltblown fibers. Such a process is disclosed, for example, in U.S. Pat. No. 3,849,241 to Butin, the disclosure of which is hereby incorporated by reference.
As used herein, the term xe2x80x9cmicrofibersxe2x80x9d means small diameter fibers having an average diameter not greater than about 100 microns, for example, having an average diameter of from about 0.5 microns to about 50 microns, or more particularly, microfibers may have an average diameter of from about 4 microns to about 40 microns.
As used herein, the terms xe2x80x9cspunbondxe2x80x9d, xe2x80x9cspunbonded fibersxe2x80x9d or xe2x80x9cspunbond filamentsxe2x80x9d refer to small diameter fibers which are formed by extruding a molten thermoplastic material as filaments from a plurality of fine, usually circular, capillaries of a spinneret with the diameter of the extruded filaments then being rapidly reduced as by, for example, eductive drawing or other well-known spunbonding mechanisms. The production of spun-bonded nonwoven webs is illustrated in patents such as, for example, in U.S. Pat. No. 4,340,563 to Appel et al., and U.S. Pat. No. 3,692,618 to Dorschner et al. The disclosures of these patents are hereby incorporated by reference.
As used herein the terms xe2x80x9csubstratexe2x80x9d, xe2x80x9csurfacexe2x80x9d, or xe2x80x9csheetxe2x80x9d means a layer that may be a film or woven web or nonwoven web, a laminate; pervious or impervious to air, gas, and/or liquids; or a composite structure comprising for example a topsheet, backsheet, and an absorbent medium therebetween.
As used herein the xe2x80x9clayerxe2x80x9d when used in the singular can have the dual meaning of a single element or a plurality of elements.
As used herein the term xe2x80x9claminatexe2x80x9d includes any multilayer material where the layers are joined together.
As used herein xe2x80x9cSMS laminatexe2x80x9d means a spunbond/meltblown/spunbond (SMS) laminate. Examples of multilayer nonwoven laminates are disclosed in U.S. Pat. No. 4,041,203 to Brock et al., U.S. Pat. No. 5,178,931 to Perkins et al. and U.S. Pat. No. 5,188,885 to Timmons et al. Such a laminate may be made by sequentially depositing onto a moving forming belt first a spunbond fabric layer, then a meltblown fabric layer and last another spunbond layer and then bonding the laminate such as by thermal point bonding as described below. Alternatively, the fabric layers may be made individually, collected in rolls, and combined in a separate bonding step.
As used herein the term xe2x80x9cpalindromicxe2x80x9d means a multilayer laminate which is substantially symmetrical. Examples of palindromic laminates would have layer configurations of A/B/A, A/B/B/A, A/A/B/B/A/A, A/B/C/B/A, etc. Examples of non-palindromic layer configurations would include A/B/C, A/B/C/A, A/B/C/D, etc.
As used herein the term xe2x80x9cpolymerxe2x80x9d generally includes but is not limited to, homopolymers, copolymers, such as for example, block, graft, random and alternating copolymers, terpolymers, etc. and blends and modifications thereof. Furthermore, unless otherwise specifically limited, the term xe2x80x9cpolymerxe2x80x9d includes all possible special configurations of the molecule. These configurations include, but are not limited to isotactic, syndiotactic and random symmetries.
As used herein the term xe2x80x9camorphous polymerxe2x80x9d, when used herein to describe a bonding layer either as an intermediate layer or a separately applied layer, means a thermoplastic polymer such as certain polyolefins with a density in the range of from about 0.85 to about 0.89 g/cm.sup.3 and low crystallinity, for example, less than about 30.
As used herein, the term xe2x80x9cbarrierxe2x80x9d means a film, laminate or other fabric which is substantially impermeable to the transmission of liquids and which has a hydrohead of at least 50 mbar water. Hydrohead as used herein refers to a measure of the liquid barrier properties of a fabric. However, it should be noted that barrier fabrics of the present invention can have a hydrohead value greater than 80 mbar, 150 mbar or even 300 mbar water.
As used herein, the term xe2x80x9cbreathablexe2x80x9d refers to a material which is permeable to water vapor having a minimum WVTR of about 300 g/m2/24 hours. The WVTR of a fabric is water vapor transmission rate which, in one aspect, gives an indication of how comfortable a fabric would be to wear. WVTR (water vapor transmission rate) is measured as indicated below and the results are reported in grams/square meter/day. However, often applications of breathable barriers desirably have higher WVTRs and breathable laminates of the present invention can have WVTRs exceeding about 800 g/m m2/day, 1500 g/m2/day, or even exceeding 3000 g/m2/day.
As used herein the term xe2x80x9cmonolithicxe2x80x9d means an unfilled film or film layer.
As used herein, the term xe2x80x9csuperabsorbentxe2x80x9d refers to absorbent materials capable of absorbing at least 10 grams of aqueous liquid (e.g. distilled water per gram of absorbent material while immersed in the liquid for 4 hours and holding substantially all of the absorbed liquid while under a compression force of up to about 1.5 psi.
As used herein, the term xe2x80x9cconsisting essentially ofxe2x80x9d does not exclude the presence of additional materials which do not significantly affect the desired characteristics of a given composition or product. Exemplary materials of this sort would include, without limitation, pigments, antioxidants, stabilizers, surfactants, waxes, flow promoters, particulates and materials added to enhance processability of the composition.
Thus, a need exists for an inexpensive material which is absorbent, elastic, compressible and suitable for use as a bandage. There is also a need for a bandage having the additional properties of being relatively tough, durable, absorbent, lightweight and permeable to air and water vapor while exhibiting barrier properties against bacterial and liquid entry. For example, a need exists for a self-adhesive wrap or bandage composed substantially or entirely of materials such that the bandage is elastic, compressible, relatively permeable to air and/or water vapor, relatively impermeable to liquid entry, and so inexpensive as to be considered disposable.
Problems associated with previous self-adhesive elastic bandages have been addressed by the multi-layer, absorbent, breathable, compressive elastic bandage of the present invention.
One type of bandage useful in the present invention is referred to as a stretch-bonded laminate. Such a stretch-bonded laminate may be made as generally described, for example, in U.S. Pat. No. 4,720,415 to Vander Wielen et al., U.S. Pat. No. 6,096,668 to Abuto et al., and U.S. Pat. No. 5,964,973 to Heath et al., as well as U.S. Pat. No. 5,503,908 to Faass, issued Apr. 2, 1996 which are hereby incorporated by reference in their entirety.
In one possible embodiment, the elastic bandage may comprise a laminate that is reversibly extensible in at least one direction, desirably along the length of the bandage. For example, the laminate may comprise a plurality of elastomeric nonwoven fibrous strands in combination with at least one nonelastic absorbent nonwoven web. Additionally, the bandage may comprise a breathable liquid barrier layer. This barrier layer may be a film or more desirably a film incorporated as a layer within a second nonelastic nonwoven web. The elastomeric nonwoven fibrous strands may be attached to the first nonelastic nonwoven web and the second nonelastic nonwoven web or the stand alone film under stretched or partially stretched conditions. The elastomeric nonwoven fibrous strands are situated so that they lie between the first nonelastic nonwoven web and the second nonelastic nonwoven web or between the first nonelastic nonwoven web and the film. When the elastomeric nonwoven fibrous strands are attached to the nonelastic nonwoven webs and subsequently allowed to relax, the entire laminate is caused to gather into small folds or wrinkles substantially normal to the length of the elastomeric strands. This arrangement creates a multi-layer bandage having a first and a second surface and a z-direction thickness. The attachment of the elastomeric nonwoven fibrous strands to the nonelastic nonwoven webs can be by thermal point bonding, adhesives, and other means that serve to attach the threads to the webs.
In other embodiments of the present invention, the elastomeric nonwoven fibrous strands or elastomeric filaments may be incorporated into an elastomeric composite web desirably constructed of a nonwoven web of elastomeric fibers which may include meltblown microfibers. In one aspect of the present invention, the elastomeric composite web is a coherent stretchable sheet which can distribute tensioning forces across its width without creating pressure points or areas of concentrated tension. The elastomeric meltblown fibers may be an elastomeric polymer such as, for example, elastomeric polyesters, elastomeric polyurethanes, elastomeric polyamides, elastomeric copolymers of ethylene and at least one vinyl monomer, and elastomeric A-B-Axe2x80x2 block copolymers wherein A and Axe2x80x2 are the same or different thermoplastic polymer, and wherein B is an elastomeric polymer block or a combination of blocks. The elastomeric polymer may be blended with a processing aid.
In one aspect of the present invention, the elastic composite web may be an anisotropic nonwoven fibrous web containing a substantially homogenous arrangement of meltblown fibers generally aligned along one of the planar dimensions of the web, for example the MD or machine direction. The elastomeric meltblown fibers may also comprise a mixture of elastomeric meltblown fibers and one or more other materials such as, for example, wood pulp, staple-type fibers, particulates or super-absorbent materials. For example, the staple-type fibers may be polyester fibers, polyamide fibers, glass fibers, polyolefin fibers, cellulosic derived fibers, multi-component fibers, natural fibers, absorbent fibers, electrically conductive fibers or blends of two or more of said fibers. The particulate materials may be, for example, activated charcoal, clays, starches, and metal oxides.
In some embodiments, one of the surfaces of the bandage may be self-adherent. In any of the embodiments the barrier layer may comprise a breathable film, non-breathable film, or coating which itself could comprise a separate layer or could be integrated into one of the nonelastic nonwoven webs. The bandage may also be used in combination with a separate dressing or gauze. According to another aspect of the present invention, the elastic component may also comprise an elastomeric web.
In each of the embodiments, a mechanism is desirable to enable the bandage to be applied to a patient in a stretched and secured relation. Examples of such a mechanism include but are not limited to an adhesive self-adherent coating applied to at least one of the surfaces of the bandage, a hook and loop type fastener, an additional wrap, and tape. If an adhesive self-adherent coating or self-adhesive material is used, desirably, the self adhesive material may be applied on at least a portion of at least one exterior surface of the elastomeric composite material so that the peel strength of the self adhesive material is less than the peel strength of the layers of the elastic composite material. In other words, the peel strength of such a material would be less than the peel strength which attaches the elastomeric nonwoven fibrous strands or elastomeric strands to the nonwoven laminate. For example, the peel strength of the self-adhesive material may be at least about 5 percent less than the peel strength which attaches the materials together. As another example, the peel strength of the self-adhesive material may be from about 10 to about 98 percent less than the peel strength which attaches the materials together. As a further example, the peel strength of the self-adhesive material may be from about 20 to about 95 percent less than the peel strength which attaches the materials together. Desirably, the peel strength of the self-adhesive material will be from about 0.1 to about 1.0 pound per inch. For example, the peel strength of the self-adhesive material may be from about 0.3 to about 0.5 pound per inch. Desirably, the amount of force required to unwind a roll of the self-adhesive material will be from about 0.3 to about 2.0 pounds per inch. For example, the amount of force required to unwind a roll of the self-adhesive material may be from about 0.5 to about 1.2 pounds per inch.
The use of a thin film as a barrier layer is advantageous for a number of reasons. A desirable film would be impermeable to liquid water and bacteria and as such would form a very effective shield, which protects a patient from sources of infection external to the skin. The film would also serve to retain body fluids within the body at the site of the wound. The vapor permeability of a breathable film provides a sufficient rate of water vapor transport through the film to allow the skin to breathe normally. In spite of the many advantages of the thin film, some problems exist when it is used alone. As such, desirably the film is used with some form of backing sheet or release sheet since due to its extreme flexibility and limpness, the film may curl over upon itself. Additionally, because of its extreme thinness, the film is fragile and can readily catch on a sharp or rough object resulting in a tearing. Furthermore, the film may stick to itself adding to the difficulty in applying the bandages to a patient. As such it is desirable in any of the embodiments to attach the film to a lightweight nonelastic nonwoven fabric. Desirably the nonwoven fabric could comprise a fabric of about 0.6 osy or less. The combination of a lightweight nonwoven and thin film used in conjunction with the bandage enhances the ability of the bandage to conform to the shape of various parts of the body, even a flexible body part such as a knee or elbow.
Furthermore, according to one aspect of the present invention, the film may comprise a monolithic polyurethane film bonded to a nonelastic nonwoven web, a breathable microporous film, or other suitable breathable liquid barrier. The film may further comprise a polymer and filler wherein microporous voids are located adjacent the filler. The barrier may also comprise a polymer having the inherent ability to transport vapors across the barrier without the presence of a microporous structure.
According to one aspect of the present invention, the coating of self-adhesive material may be located on at least one surface of an outermost layer of the laminate. In some embodiments, the coating of self-adhesive material may be located only on raised portions of gathers formed by the nonelastic material gathering into the small folds or wrinkles created in the material. The coating of self adhesive material may be in the form of a randomly scattered network of hot-melt adhesive filaments and/or fibers. The coating of self-adhesive material may be a coating of any suitable conventional commercially available hot-melt adhesive such as, for example, hot melt adhesives which may be based on blends of polyolefins, adhesive resins, and waxes.
According to the present invention, the nonwoven webs of the present invention may comprise nonwoven webs of fibers such as, for example, webs of spunbonded fibers, webs of meltblown fibers, bonded carded webs of fibers, multi-layer materials including at least one of the webs of spunbonded fibers, meltblown fibers, or a bonded carded web of fibers. One such substrate is designed to be placed proximal to the wound bed. This substrate should be absorbent and may be inherently absorbent or may be treated to create or enhance absorbency by such means as surfactant treatment of a naturally hydrophobic material. Additionally, this substrate may also comprise a nonadherent wound contacting layer so that the bandage does not adhere to the wound bed. Another substrate serves as a protective barrier to prevent the passage of external liquids through the bandage. Desirably the film barrier is attached to or incorporated within this substrate. In some aspects of the present invention, the nonwoven webs form gatherable layers when attached to the elastomeric materials. The substrates may also comprise composite materials composed of a mixture of fibers and one or more other materials such as, for example, wood pulp, staple fibers, particulates or super-absorbent materials. Medicinal materials may be mixed with the fibrous materials.
In yet another aspect of the present invention, the bandage may have a stretch-to-stop elongation of at least about 25 percent. For example, the stretch-to-stop elongation may range from about 35 to about 400 percent or more.